Insmed Incorporated, a global biopharmaceutical company focused on serious diseases, has received US Food and Drug Administration (FDA) approval for BRINSUPRI (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for adults and children 12 years and older with non-cystic fibrosis bronchiectasis (NCFB). BRINSUPRI is the first and only FDA-approved therapy for NCFB, targeting neutrophilic inflammation to address a root cause of exacerbations.

“This FDA approval represents a potential paradigm shift in how we approach NCFB,” said Doreen Addrizzo-Harris, professor of pulmonary, critical care, and sleep medicine at NYU Grossman School of Medicine and director of the NYU Langone Health Bronchiectasis and NTM Program. “For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of NCFB exacerbations.”

NCFB is a serious, chronic, and progressive inflammatory lung disease in which bronchi become permanently dilated due to cycles of infection, inflammation, lung tissue damage, and mucociliary dysfunction. Patients frequently experience pulmonary exacerbations that require antibiotics or hospitalization, with symptoms including chronic cough, excessive sputum production, shortness of breath, fatigue, and recurrent respiratory infections. NCFB affects an estimated 500,000 patients in the US, 400,000 across France, Germany, Italy, and Spain, and approximately 300,000 in the UK.

Elisha Malanga, executive director of the Bronchiectasis and NTM Association, added: “NCFB deeply affects the lives of people living with this chronic lung condition, impacting both their physical health and emotional well-being. Many patients experience frequent flares, which can disrupt daily life and potentially lead to disease progression.”

The FDA approval is supported by data from the Phase 3 ASPEN and Phase 2 WILLOW studies. Both brensocatib doses significantly reduced the annualized rate of pulmonary exacerbations compared with placebo over 52 weeks, prolonged time to first exacerbation, and increased the proportion of patients remaining exacerbation-free. Patients receiving 25 mg of brensocatib also showed less decline in lung function, measured by FEV.

The safety profile of BRINSUPRI was generally consistent across studies. The most common adverse reactions included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension, with an increase in dermatologic and gingival/periodontal reactions noted in some patients.

Martina Flammer, chief medical officer of Insmed, said: “The FDA approval of this treatment for NCFB is a historic milestone for patients and for Insmed.

“We’re deeply grateful to the patients and healthcare providers who made this possible – this is just the beginning of what we can accomplish together for this community.”

BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor that prevents activation of neutrophil serine proteases, key drivers of chronic airway inflammation. Applications for approval are under review with the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), with a planned filing in Japan in 2025.